A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT05037929
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1334
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive SC placebo Q2W. Astegolimab Q2W Astegolimab Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W). Astegolimab Q4W Astegolimab Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
- Primary Outcome Measures
Name Time Method Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period Baseline up to Week 52
- Secondary Outcome Measures
Name Time Method Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score Baseline to Week 52 Proportion of SGRQ-C Responders at Week 52 Baseline to Week 52 Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 Baseline to Week 52 Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period Baseline up to Week 52 Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 Baseline to Week 52 Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period Baseline up to Week 52 Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 Baseline to Week 52
Trial Locations
- Locations (170)
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Centro de Investigacion del Maule
🇨🇱Talca, Chile
Praxis Dr. Med Evelin Liefring
🇩🇪Berlin, Germany
Gemeinscharftspraxis Dres Jung - Deggingen
🇩🇪Deggingen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Germany
Praxis Dr med Claus Keller
🇩🇪Frankfurt am Main, Germany
Dr A.C Wilhase practice-Reimed
🇿🇦Ekurhuleni, South Africa
Langeberg Clinical Trials
🇿🇦Kraaifontein, South Africa
Hospital de Merida
🇪🇸Merida, Badajoz, Spain
ProbarE i Lund AB
🇸🇪Lund, Sweden
PharmaSite
🇸🇪Malmö, Sweden
ProbarE i Stockholm AB
🇸🇪Stockholm, Sweden
Instituto de Medicina Respiratoria, IMeR
🇦🇷Córdoba, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica
🇦🇷Florencio Varela, Argentina
Centro de Especialidades Medicas Lobos
🇦🇷Lobos, Argentina
Centro de Investigaciones Medicas Mar Del Plata
🇦🇷Mar Del Plata, Argentina
Instituto Ave Pulmo
🇦🇷Mar Del Plata, Argentina
Fundacion Scherbovsky
🇦🇷Mendoza, Argentina
INSARES
🇦🇷Mendoza, Argentina
Centro Respiratorio Quilmes
🇦🇷Quilmes, Argentina
Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica
🇦🇷Rosario, Argentina
Centro Medico IPAM
🇦🇷Rosario, Argentina
Centro Médico Respire
🇦🇷San Fernando, Argentina
Investigaciones en Patologias Respiratorias
🇦🇷San Miguel de Tucuman, Argentina
Plicni Ambulance Kralupy nad Vltavou
🇨🇿Kralupy nad Vltavou, Czechia
MUDr. Ilona Pavlisova s.r.o.
🇨🇿Miroslav, Czechia
Pneumologie Varnsdorf S.r.o.
🇨🇿Novy Bor, Czechia
KASMED s.r.o.
🇨🇿Tábor, Czechia
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Gentofte Hospital
🇩🇰Hellerup, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Odense Universitetshospital
🇩🇰Odense, Denmark
Sygehus Lillebælt, Vejle
🇩🇰Vejle, Denmark
Hôpital de La Croix Rousse
🇫🇷Lyon, France
CHU de Nice
🇫🇷Nice Cedex 1, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
🇩🇪Augsburg, Germany
CIMS-Studienzentrum Bamberg,
🇩🇪Bamberg, Germany
KPPK Studienzentrum Kroker-Schmidt
🇩🇪Bendorf, Germany
MECS Research GmbH
🇩🇪Berlin, Germany
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
🇷🇴Brasov, Romania
Dr. Victor Babes Foundation
🇷🇴Bucuresti, Romania
Leon Daniello Pneumophthisiology Clinical Hospital
🇷🇴Cluj-Napoca, Romania
Spitalul Clinic de Pneumoftiziologie Constanta
🇷🇴Constanta, Romania
Sf. Ioan cel Nou Emergency County Hospital
🇷🇴Suceava, Romania
University of Cape Town Lung Institute
🇿🇦Cape Town, South Africa
St Augustines Hospital
🇿🇦Durban, South Africa
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Clinica Internacional
🇵🇪Lima, Peru
Clinica Ricardo Palma
🇵🇪Lima, Peru
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
🇵🇱Bydgoszcz, Poland
Indywidualna Specjalistyczna Praktyka Lekarska lek.
🇵🇱Kielce, Poland
Centrum Medyczne ALL-MED
🇵🇱Krakow, Poland
Diamond Clinic
🇵🇱Kraków, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
🇵🇱Kraków, Poland
ETG Lublin
🇵🇱Lublin, Poland
ETG Lodz
🇵🇱Lódz, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
🇵🇱Nowa Sól, Poland
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
🇵🇱Ostrowiec Swietokrzysk, Poland
Centrum Alergologii Teresa Hofman
🇵🇱Poznan, Poland
EMED Centrum Uslug Medycznych Ewa Smialek
🇵🇱Rzeszów, Poland
ETG Siedlce
🇵🇱Siedlce, Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
🇵🇱Sosnowiec, Poland
ETG Warszawa- PPDS
🇵🇱Warszawa, Poland
Queen Anne Street Medical Centre
🇬🇧London, London, City Of, United Kingdom
Dobrostan Gabinety Lekarskie
🇵🇱Wroclaw, Poland
Cadena Care Institute, LLC
🇺🇸Poway, California, United States
Fundacion Cidea
🇦🇷Buenos Aires, Argentina
Jasper Summit Research LLC
🇺🇸Jasper, Alabama, United States
Pulmonary Associates of Mobile PC
🇺🇸Mobile, Alabama, United States
Medical Centre Respiro OOD
🇧🇬Razgrad, Bulgaria
Inst. of Healthcare Assessment, Inc.
🇺🇸San Diego, California, United States
Allianz Research Institute Inc
🇺🇸Westminster, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
🇺🇸Leesburg, Florida, United States
Pulmonary Specialists of the Palm Beaches
🇺🇸Loxahatchee Groves, Florida, United States
Florida Institute for Clinical Research, LLC
🇺🇸Orlando, Florida, United States
Northwestern Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Medisphere Medical Research Center, Llc
🇺🇸Evansville, Indiana, United States
Exordia Medical Research, Inc.
🇺🇸Fall River, Massachusetts, United States
Northern Pines Health Center PC
🇺🇸Buckley, Michigan, United States
Revive Research Institute
🇺🇸Lathrup Village, Michigan, United States
Blessing Health Hannibal
🇺🇸Hannibal, Missouri, United States
Midwest Chest Consultants
🇺🇸Saint Charles, Missouri, United States
CARE Clinical Research
🇺🇸Saint Louis, Missouri, United States
Sierra Clinical Research - ClinEdge - PPDS
🇺🇸Las Vegas, Nevada, United States
American Health Research Inc.
🇺🇸Charlotte, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
🇺🇸North Charleston, South Carolina, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Velocity Clinical Research Spartanburg PPDS
🇺🇸Spartanburg, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Metroplex Pulmonology & Sleep Center
🇺🇸McKinney, Texas, United States
Sherman Clinical Research - ClinEdge - PPDS
🇺🇸Sherman, Texas, United States
CARE - Centro de Alergia y Enfermedades Respiratorias
🇦🇷Caba, Argentina
Centro Médico Dra de Salvo
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Centro de Investigaciones Clínicas Belgrano
🇦🇷Ciudad Autónoma De Buenos Aires, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
🇦🇷San Miguel De Tucuman, Argentina
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
UZ Antwerpen
🇧🇪Edegem, Belgium
Private Practice Dr Jean Benoit Martinot
🇧🇪Erpent, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
CHU UCl Namur asbl - Site Godinne
🇧🇪Yvoir, Belgium
Medical Centre "Asklepii", OOD
🇧🇬Dupnitsa, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
🇧🇬Haskovo, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
🇧🇬Pazardzhik, Bulgaria
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
🇧🇬Pernik, Bulgaria
Medical center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Medical center Unimed EOOD
🇧🇬Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
🇧🇬Sofia, Bulgaria
Medical Center New rehabilitation center EOOD
🇧🇬Stara Zagora, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
🇧🇬Vratsa, Bulgaria
Burlington Lung Clinic
🇨🇦Burlington, Ontario, Canada
St. Joseph's Healthcare Hamilton- Charlton Campus
🇨🇦Hamilton, Ontario, Canada
Bluewater Clinical Research Group
🇨🇦Sarnia, Ontario, Canada
University of Saskatchewan, Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Centro de Investigaciones Medicas Respiratorias
🇨🇱Providencia, Región-MetropolitanadeSantiago, Chile
Centro de Investigación Curico
🇨🇱Curico, Chile
Sociedad Médica SyG SpA
🇨🇱Providencia, Chile
Enroll SpA - PPDS
🇨🇱Providencia, Chile
Meditek Ltda
🇨🇱Santiago, Chile
Hospital Carlos Van Buren
🇨🇱Valparaiso, Chile
MIRES/MYF estudios clinicos
🇨🇱Ñuñoa, Chile
MediTrial s.r.o.
🇨🇿Jind?ich?v Hradec, Czechia
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Asklepios MVZ Bayern GmbH
🇩🇪Landsberg, Germany
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
🇩🇪Marburg, Germany
Studienzentrum Dr Med Schlenska
🇩🇪Peine, Germany
Tuen Mun Hospital
🇭🇰Hong Kong, Hong Kong
Assuta Ashdod Medical Center
🇮🇱Ashdod, Israel
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Shamir Medical Center Assaf Harofeh
🇮🇱Beer Jacob, Israel
Tel Aviv Sourasky Medical Center PPDS
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tiqwa, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Catholic Univ. of Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
CICUM San Miguel
🇲🇽Guadalajara Centro, Jalisco, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Unidad Medica de Occidente
🇲🇽Guadalajara, Jalisco, Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
🇲🇽Monterrey, Nuevo LEON, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
🇲🇽Durango, Mexico
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Aotearoa Clinical Trials Trust
🇳🇿Auckland, New Zealand
Canterbury Respiratory Research Group
🇳🇿Christchurch, New Zealand
Medicentro Biociencias Peru S.R.L.
🇵🇪Lima, Peru
Clinica Providencia (Inverconsult Sociedad Anonima)
🇵🇪Lima, Peru
CHUS H Clinico U de Santiago
🇪🇸Santiago de Compostela, LA Coruna, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital de San Pedro de Alcantara
🇪🇸Caceres, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz.
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Fysikalisk Medicin i Stockholm AB
🇸🇪Lidingö, Sweden
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom